On March 11, 2025 Champions Oncology, Inc. (Nasdaq: CSBR), a global preclinical and clinical research services provider that offers end-to-end oncology solutions, reported its financial results for its third quarter of fiscal 2025, ended January 31, 2025 (Filing, 3 mnth, DEC 31, Champions Oncology, 2024, MAR 11, 2025, View Source [SID1234651077]).

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Third Quarter and Recent Highlights:

•Total revenue increased 42% to $17.0 million
•Gross profit of $10.4 million; gross margin of 61%
•Net income of approximately $4.5 million
•Adjusted EBITDA of $5.2 million
•Signed first data licensing deal worth up to $8.0 million
•Hired Matt Newman, Executive Vice President and General Manager, to lead and expand the development of Champions’ data licensing platform

Year to Date Highlights:

•Total revenue increased 23% to $44.6 million
•Gross profit of $23.5 million; gross margin of 53%
•Net income of $6.5 million
•Adjusted EBITDA of $8.3 million

Ronnie Morris, CEO of Champions, commented, "Our third quarter was transformational, marked by our first major data licensing agreement – an important milestone toward monetizing our proprietary

Exhibit 99.1
data platform." Added Morris, "Despite ongoing funding constraints in the pharma and biotech sectors, we continue to drive strong performance in our core services business."

David Miller, CFO of Champions, added, "We delivered record breaking financial results this quarter, with revenue surpassing $17.0 million and adjusted EBITDA reaching $5.2 million. While we anticipate some fluctuations in quarterly revenue, our strategic cost realignment positions us for sustained long-term profitability."

Third Fiscal Quarter Financial Results

Total oncology revenue for the third quarter of fiscal 2025 was $17.0 million compared to $12.0 million for the same period last year, an increase of 42%. The increase stemmed from a 4% increase in our research services business and $4.5 million from data license revenue. Total costs and operating expenses for the third quarter of fiscal 2025 were $12.5 million compared to $14.6 million for the third quarter of fiscal 2024, a decrease of $2.1 million or 14.1%.

For the third quarter of fiscal 2025, Champions reported income from operations of $4.5 million, including $256,000 in stock-based compensation and $398,000 in depreciation and amortization expenses, compared to a loss from operations of $2.6 million, inclusive of $379,000 in stock-based compensation and $481,000 in depreciation and amortization expenses, in the third quarter of fiscal 2024. Adjusted EBITDA, which is defined as income from operations excluding stock-based compensation, depreciation and amortization expenses, was $5.2 million for the third quarter of fiscal 2025 compared to an adjusted EBITDA loss of $1.7 million in the third quarter of fiscal 2024.

Cost of oncology revenue was $6.6 million for the three-months ended January 31, 2025, a decrease of $1.2 million, or 15.7% compared to $7.8 million for the three-months ended January 31, 2024. The decrease in cost of oncology revenue was primarily from a decrease in compensation and lab supply costs due to our recent emphasis on improving efficiencies and reducing costs along with a reduction in outsourced lab services which fluctuate quarterly in the ordinary course of business. For the three-months ended January 31, 2025, total margin was 61%, with research services margin of 48% compared to 35% for the three-months ended January 31, 2024. The increase in revenue coupled with our cost reductions led to improved service margins.

Research and development expense for the three-months ended January 31, 2025 was $1.7 million, a decrease of $467,000 or 21.4%, compared to $2.2 million for the three-months ended January 31, 2024. The decrease was primarily due to reduced investment in our wholly owned subsidiary, Corellia, focused on target discovery. Sales and marketing expense for the three-months ended January 31, 2025 was $1.8 million, essentially flat with a nominal increase of $9,000, or 0.5%, compared to $1.8 million for the three-months ended January 31, 2024. General and administrative expense for the three-months ended January 31, 2025 was $2.4 million, a decrease of $366,000, or 13.2%, compared to $2.8 million for the three-months ended January 31, 2024. The decrease was primarily from a decline in compensation expense and non-cash items of stock-based compensation and depreciation and amortization.

Net cash provided by operating activities was approximately $918,000 for the three-months ended January 31, 2025 and was primarily due to net income for the quarter offset by an increase in accounts receivable. Net cash used in investing activities for the three-months ended January 31, 2025 was approximately $470,000 for lab and computer equipment. Net cash provided by financing activities for the three-months ended January 31, 2025 was nil resulting from proceeds from options exercise of approximately $38,000 offset by financing lease payments of approximately $38,000.

On March 11, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, reported financial results and business highlights for the fourth quarter and year ended December 31, 2024 (Filing, 3 mnth, DEC 31, Lyell Immunopharma, 2025, MAR 11, 2025, View Source [SID1234651078]).

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"Last year was transformative for Lyell and now, based on promising emerging clinical data, we are poised to initiate pivotal development of IMPT-314, our next-generation dual-targeting CD19/CD20 CAR T-cell product candidate for patients with aggressive large B‑cell lymphoma," said Lynn Seely, M.D., Lyell’s President and CEO. "We believe IMPT-314 has the potential to deliver improved outcomes for patients by increasing complete response rates and prolonging the duration of response over approved CD19 CAR T-cell therapies, and this year we expect to share more mature data from the ongoing Phase 1/2 trial of IMPT-314. We also plan to initiate two pivotal programs for IMPT-314: one for patients in the 3rd line and later setting by the middle of this year and a second program for patients in the 2nd line setting by early 2026. In addition, we expect to submit a new IND in 2026 for a next-generation solid tumor CAR T-cell product candidate with a new target that is fully-armed with a suite of technologies, including our proprietary clinically-validated anti-exhaustion technology. Our strong cash position enables us to advance our pipeline through important clinical milestones and fund operations into 2027."
Fourth Quarter Updates and Recent Business Highlights
Lyell is advancing a pipeline of next-generation CAR T-cell product candidates. Its lead program, IMPT-314, is in Phase 1/2 clinical development for relapsed or refractory aggressive large B-cell lymphoma (LBCL) and its preclinical programs target solid tumor indications. Lyell’s programs target cancers with large unmet need with substantial patient populations.
IMPT-314: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL
IMPT-314 is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L+ cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The ongoing Phase 1/2 clinical trial is a multi-center, open-label study designed to evaluate the tolerability and clinical benefit of IMPT-314 in patients with relapsed/refractory LBCL and determine a recommended Phase 2 dose. IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma in the 3rd line and later (3rd line+) setting.

•A Phase 1/2 clinical trial is ongoing and currently enrolling patients in the 3rd line+ and 2nd line settings who have not previously received CAR T-cell therapy.
•Initial data from the Phase 1/2 trial was presented at the American Society for Hematology 2024 Annual Meeting on December 9, 2024. Data from 23 patients with relapsed or refractory, CAR T-naive LBCL who received IMPT-314 were reported. The efficacy evaluable population consisted of 17 patients. The overall response rate was 94% (16/17 patients), with 71% (12/17 patients) achieving a complete response by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and 71% of patients were experiencing a response at last follow-up. In the safety evaluable population of 23 patients, no Grade 3+ CRS was reported. Grade 3 ICANS was reported in 13% (3/23) of patients with a median time to ICANS resolution of 5 days, and rapid improvement to Grade 2 or lower with standard therapy.
•More mature data from the ongoing Phase 1/2 trial in the 3rd line+ setting and initial data from patients in the 2nd line setting are expected to be presented in mid-2025.
•Pivotal trial in the 3rd line+ setting is expected to be initiated in mid-2025 in patients with relapsed/refractory aggressive LBCL who have not previously received CAR T-cell therapy.
•Pivotal trial in the 2nd line setting expected to be initiated by early 2026 in patients with relapsed/refractory aggressive LBCL who have not previously received CAR T-cell therapy.
Preclinical Pipeline, Technologies and Manufacturing Protocols
•The first IND for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026. Lyell is advancing next-generation fully-armed CAR T-cell product candidates, meaning they are armed with multiple technologies, each designed to address different barriers to effective cell therapies, including T-cell exhaustion, lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment.
•Presented nonclinical and clinical data from cell therapy product candidates incorporating anti‑exhaustion and manufacturing technologies that demonstrated the potential of Lyell’s technologies to improve T‑cell function in solid tumors. These presentations, from multiple scientific conferences throughout the year, can be found at View Source
Corporate Updates
•Streamlined expenses and expect net cash use in 2025 to be between $175 million – $185 million. The disciplined expense management will be accomplished by focusing clinical development efforts on the pivotal trials of IMPT-314 and research efforts on developing next-generation fully-armed CAR T-cell programs for solid tumors.
Fourth Quarter and Full Year 2024 Financial Results
Lyell reported a net loss of $191.9 million and $343.0 million for the fourth quarter and year ended December 31, 2024, respectively, compared to a net loss of $52.9 million and $234.6 million for the same periods in 2023. Net loss for the fourth quarter and year ended December 31, 2024 included $87.2 million in acquired in-process research and development (IPR&D) expense as part of our acquisition of ImmPACT Bio USA Inc (ImmPACT Bio) and $51.3 million of long‑lived asset impairment expense. Non‑GAAP net loss, which excludes stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities, acquired IPR&D expense, long‑lived asset impairment expense and certain non-cash investment gains and charges, was $45.9 million and $159.5 million for the fourth quarter and year ended December 31, 2024, respectively, compared to $43.9 million and $177.4 million for the same periods in 2023.

GAAP and Non-GAAP Operating Expenses
•Research and development (R&D) expenses were $48.7 million and $171.6 million for the fourth quarter and year ended December 31, 2024, respectively, compared to $47.0 million and $182.9 million for the same periods in 2023. The increase in fourth quarter 2024 R&D expenses of $1.7 million was primarily due to increased facilities costs. The decrease in annual 2024 R&D expenses of $11.3 million was primarily driven by a $14.0 million decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce, partially offset by a $3.2 million increase in research activities primarily driven by clinical trial activity. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, for the fourth quarter and year ended December 31, 2024 were $45.4 million and $157.3 million, respectively, compared to $42.9 million and $165.7 million for the same periods in 2023. The $2.5 million increase in fourth quarter 2024 non-GAAP R&D expenses was primarily driven by increased facilities costs. The $8.3 million decrease in annual 2024 non-GAAP R&D expenses was primarily driven by the decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce.
•General and administrative (G&A) expenses were $14.5 million and $52.0 million for the fourth quarter and year ended December 31, 2024, respectively, compared to $13.2 million and $67.0 million for the same periods in 2023. The decrease in annual 2024 G&A expenses of $14.9 million was primarily driven by a decrease in non‑cash stock-based compensation. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the fourth quarter and year ended December 31, 2024 were $9.7 million and $33.5 million, respectively, compared to $8.5 million and $38.1 million for the same periods in 2023. The $1.3 million increase in fourth quarter 2024 non-GAAP G&A expenses was primarily driven by acquisition-related personnel expenses. The $4.6 million decrease in annual 2024 non-GAAP G&A expenses was primarily driven by the decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce.
•Operating expenses for the fourth quarter and year ended December 31, 2024, include $87.2 million of acquired IPR&D expenses recognized as a part of the acquisition of ImmPACT Bio. Additionally, operating expenses for the fourth quarter and year ended December 31, 2024, include an impairment charge of $51.3 million for long-lived assets, resulting from the continued decline in our stock price and related market capitalization.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of December 31, 2024 were $383.5 million compared to $562.7 million as of December 31, 2023. Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2027.

On March 11, 2025 GenScript reported financial results for fourth quarter and the year ended December 31, 2024 (Press release, GenScript, MAR 11, 2025, View Source [SID1234652188]).

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On March 11, 2025 Alpha Teknova, Inc. ("Teknova") (Nasdaq: TKNO), and Pluristyx, Inc., reported that the companies are collaborating to produce and commercialize Pluristyx’s PluriFreeze product line, a cryopreservative and cell wash media system intended for use by customers who are developing next generation allogeneic cell therapies (Press release, panCELLa, MAR 11, 2025, View Source [SID1234651079]). Teknova is a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, while Pluristyx is a leading provider of induced Pluripotent Stem Cells (iPSCs), including immune evading and safety-switch enabled iPSCs, and other innovative technologies designed to shorten the development lifecycle of tomorrow’s cell therapies.

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Through their development of iPSCs, Pluristyx recognized the critical importance of cellular biopreservation across the cell therapy workflow. In the process, the company identified a novel cryopreservation formulation for the systematic freezing of cells that streamlines the manufacture of cell products. Pluristyx launched the PluriFreeze product line as a protective wash paired with a cryopreservative designed to simplify the scale-up process for companies working to bring allogeneic cell therapies to market. The collaboration between Pluristyx and Teknova will enable wider customer access to PluriFreeze by making Teknova the exclusive manufacturer and distributor in the United States and Canada.

"We’re excited to announce our collaboration with Pluristyx, a true innovator in the development and commercialization of revolutionary cellular therapies," said Stephen Gunstream, Teknova’s President and Chief Executive Officer. "By coming together, we’re able to marry Teknova’s operational and commercial scale with their novel cryopreservation solution. Getting the PluriFreeze products into our customers’ hands will help them streamline the manufacture of allogeneic cell therapies as they move from research, to process development, and into clinical manufacturing."

"With almost 30 years of experience manufacturing high-quality research- and GMP-grade reagents and an established base of more than 3,000 life sciences customers, Teknova is the perfect partner to help us expand access to our proprietary PluriFreeze cryopreservation system," added Benjamin Fryer, Chief Executive Officer of Pluristyx. "As cell therapy developers focus on scaling their solutions into the clinic, it’s critical to use a trusted and scalable supply of products that ensure high cellular viability and function at multiple holding points across the workflow – not only during storage and transport."

The PluriFreeze cryopreservation system is entirely synthetic and animal-origin-free, and consists of a base wash and a freezing medium. PluriFreeze Base is a protective wash that mimics intracellular space and provides end-to-end metabolic support. PluriFreeze PF10 is a low viscosity freezing medium with 10% dimethyl sulfoxide (DMSO) that simplifies scale-up and process automation.

On March 11, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported that the first clinical trial under its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Actimab-A has been initiated (Press release, Actinium Pharmaceuticals, MAR 11, 2025, View Source [SID1234651081]). The trial (NCT06802523) will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Venetoclax in combination with HMAs (Ven-HMA) is approved for patients with newly diagnosed AML. Actimab-A, a humanized anti-CD33 antibody conjugated to Actinium-225 (Ac-225) targets CD33, a marker expressed ubiquitously on myeloid blasts in patients with AML and other hematologic malignancies. The potent alpha-particle payload Ac-225 causes lethal double strand DNA breaks for which there are no known resistance or repair mechanisms. This study will evaluate the rate and duration of Complete Remission (CR), as well as safety, including the optimal dose of Actimab-A in combination with Venetoclax and ASTX-727 for potential future studies.

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Dr. Avinash Desai, Actinium’s Chief Medical Officer, commented, "We are incredibly excited that the first Actimab-A trial initiated under our CRADA with the NCI is this triplet combination with Venetoclax and Taiho’s ASTX-727. While Ven-HMA has positively impacted outcomes in AML, a significant number of patients have poor responses or relapse quickly resulting in dismal outcomes. We believe Actimab-A’s potentially synergistic, and mutation agnostic mechanism of action can improve clinical outcomes for these patients by producing deeper remissions, including measurable residual disease negativity, that are more durable. Due to its mutation agnostic mechanism, Actimab-A can overcome high-risk features, such as TP53 mutations, and has demonstrated the ability to improve outcomes in these patients where Ven-HMA has had limited success. This triplet regimen can be conveniently administered in the outpatient setting as Venetoclax and ASTX-727 are both oral agents and Actimab-A does not require isolation given that it is an alpha-particle emitter. We are eager to collaborate with NCI on this important study to evaluate earlier intervention with a CD33 targeted radiotherapy in patients with AML."

Actimab-A in combination with Venetoclax was previously studied in a multi-center Phase 1 trial. The combination was shown to be well tolerated with manageable adverse events. Preclinical studies showed that Actimab-A can synergize with Venetoclax by depleting MCL-1, which mediates Venetoclax resistance.

Sandesh Seth, Actinium’s Chairman & CEO, said, "We believe 2025 will be a transformational year for Actimab-A and that the initiation of this triplet trial is a significant catalyst. It is our objective to establish Actimab-A as a backbone therapy across the treatment continuum of AML and other myeloid malignancies leveraging the broad expression of CD33 and the mutation agnostic Ac-225 payload. Driven by the compelling clinical results in over 150 patients in multiple treatment settings and the high visibility of our NCI CRADA, we are seeing strong enthusiasm from investigators for Actimab-A. As the only CD33 targeted radiotherapy in development for myeloid malignancies, we are focused on capitalizing on the tremendous opportunity to improve outcomes for a significant patient population that continues to have high unmet medical needs that are not addressed by current therapies. Over the course of 2025, we expect to generate preclinical data and initiate additional clinical trials that will further differentiate Actimab-A and demonstrate material progress in establishing Actimab-A as a first-in-class backbone radiotherapy for the over 100,000 patients with AML and other myeloid malignancies in the U.S. and other major international markets."